Depakote

"According to new research on epilepsy, zebrafish have certainly earned their stripes. Results of a study in Nature Communications suggest that zebrafish carrying a specific mutation may help researchers discover treatments for Dravet syndrome "...

Hepatotoxicity

Hepatic failure resulting in
fatalities has occurred in patients receiving valproate and its derivatives.
Children under the age of two years are at a considerably increased risk of
developing fatal hepatotoxicity, especially those on multiple anticonvulsants,
those with congenital metabolic disorders, those with severe seizure disorders
accompanied by mental retardation, and those with organic brain disease. When
Depakote is used in this patient group, it should be used with extreme caution
and as a sole agent. The benefits of therapy should be weighed against the
risks. The incidence of fatal hepatotoxicity decreases considerably in
progressively older patient groups.

These incidents usually have
occurred during the first six months of treatment. Serious or fatal
hepatotoxicity may be preceded by non-specific symptoms such as malaise,
weakness, lethargy, facial edema, anorexia, and vomiting. In patients with
epilepsy, a loss of seizure control may also occur. Patients should be
monitored closely for appearance of these symptoms. Liver function tests should
be performed prior to therapy and at frequent intervals thereafter, especially
during the first six months [see WARNINGS AND PRECAUTIONS].

Fetal Risk

Valproate is therefore
contraindicated in pregnant women treated for prophylaxis of migraine [see CONTRAINDICATIONS].
Valproate should only be used to treat pregnant women with epilepsy or bipolar
disorder if other medications have failed to control their symptoms or are
otherwise unacceptable.

Valproate should not be
administered to a woman of childbearing potential unless the drug is essential
to the management of her medical condition. This is especially important when
valproate use is considered for a condition not usually associated with
permanent injury or death (e.g., migraine). Women should use effective
contraception while using valproate [see WARNINGS AND PRECAUTIONS].

A Medication Guide
describing the risks of valproate is available for patients [see PATIENT INFORMATION].

Pancreatitis

Cases of life-threatening
pancreatitis have been reported in both children and adults receiving
valproate. Some of the cases have been described as hemorrhagic with a rapid
progression from initial symptoms to death. Cases have been reported shortly
after initial use as well as after several years of use. Patients and guardians
should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be
symptoms of pancreatitis that require prompt medical evaluation. If
pancreatitis is diagnosed, valproate should ordinarily be discontinued.
Alternative treatment for the underlying medical condition should be initiated
as clinically indicated [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Divalproex sodium is a stable co-ordination compound
comprised of sodium valproate and valproic acid in a 1:1 molar relationship and
formed during the partial neutralization of valproic acid with 0.5 equivalent
of sodium hydroxide. Chemically it is designated as sodium hydrogen
bis(2-propylpentanoate). Divalproex sodium has the following structure:

Divalproex sodium occurs as a
white powder with a characteristic odor.

What are the possible side effects of divalproex sodium (Depakote, Depakote ER, Depakote Sprinkles)?

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage or pancreatitis.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

What are the precautions when taking divalproex sodium delayed release tablets (Depakote)?

See also Warning section.

Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.